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TPLC
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Device
analyzer, gas, carbon-dioxide, gaseous-phase
Product Code
CCK
Regulation Number
868.1400
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
SUBSTANTIALLY EQUIVALENT
2
BLUEPOINT MEDICAL GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
CMI HEALTH INC.
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
DRAEGERWERK AG & CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
ENDURE INDUSTRIES INC
SUBSTANTIALLY EQUIVALENT
1
ENGINEERED MEDICAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE FINLAND OY
SUBSTANTIALLY EQUIVALENT
2
MASIMO CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MAXTEC, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDIPINES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
SUBSTANTIALLY EQUIVALENT
1
ORANTECH INC.
SUBSTANTIALLY EQUIVALENT
1
ORIDION MEDICAL 1987 LTD.
SUBSTANTIALLY EQUIVALENT
3
PNEUMA THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
POM MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
RESPIRION, INC.
SUBSTANTIALLY EQUIVALENT
1
REVOLUTIONARY MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K173147
SuperNO2VA Et Device
SOUTHMEDIC INC.
SUBSTANTIALLY EQUIVALENT
1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
UNIMED MEDICAL SUPPLIES, INC.
SUBSTANTIALLY EQUIVALENT
1
VYAIRE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
63
63
2019
141
141
2020
2302
2302
2021
2272
2272
2022
2475
2475
2023
1638
1638
2024
827
827
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3303
3303
Communication or Transmission Problem
2461
2461
Crack
2292
2292
Appropriate Term/Code Not Available
944
944
Corroded
938
938
Failure to Calibrate
862
862
Incorrect, Inadequate or Imprecise Result or Readings
732
732
Device Alarm System
604
604
Computer Software Problem
564
564
Contamination
517
517
Failure of Device to Self-Test
474
474
No Device Output
464
464
No Apparent Adverse Event
411
411
Loose or Intermittent Connection
405
405
Calibration Problem
361
361
Circuit Failure
300
300
Insufficient Information
295
295
Output Problem
218
218
Device Sensing Problem
180
180
Physical Resistance/Sticking
116
116
Failure to Read Input Signal
109
109
Display Difficult to Read
77
77
Display or Visual Feedback Problem
74
74
Application Program Freezes, Becomes Nonfunctional
62
62
Unable to Obtain Readings
55
55
Misassembled
48
48
Incorrect Measurement
43
43
Pumping Stopped
37
37
Failure to Power Up
37
37
Peeled/Delaminated
37
37
High Readings
34
34
Low Readings
33
33
Missing Information
29
29
Naturally Worn
28
28
Degraded
27
27
Application Program Problem
26
26
Failure to Cycle
25
25
Electrical /Electronic Property Problem
24
24
Power Problem
22
22
Gas Output Problem
20
20
Image Display Error/Artifact
18
18
Mechanical Problem
18
18
Temperature Problem
17
17
No Display/Image
16
16
Device Markings/Labelling Problem
15
15
Erratic or Intermittent Display
14
14
Unexpected Shutdown
13
13
Noise, Audible
13
13
False Alarm
12
12
Use of Device Problem
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6496
6496
No Patient Involvement
2990
2990
No Consequences Or Impact To Patient
132
132
No Known Impact Or Consequence To Patient
114
114
Insufficient Information
114
114
No Information
81
81
Unintended Extubation
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Unspecified Tissue Injury
4
4
Cardiac Arrest
3
3
Foreign Body In Patient
3
3
Death
2
2
Respiratory Distress
2
2
Hypoxia
2
2
Low Oxygen Saturation
2
2
Cyanosis
1
1
Superficial (First Degree) Burn
1
1
Patient Problem/Medical Problem
1
1
Hypersensitivity/Allergic reaction
1
1
Hypoventilation
1
1
Respiratory Arrest
1
1
Perforation
1
1
Injury
1
1
Chest Pain
1
1
Discomfort
1
1
Cardiopulmonary Arrest
1
1
Laceration(s)
1
1
Pain
1
1
Anxiety
1
1
Cough
1
1
Pressure Sores
1
1
Inadequate Pain Relief
1
1
Extubate
1
1
Respiratory Insufficiency
1
1
Lethargy
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CareFusion 303, Inc.
II
Aug-30-2019
2
Covidien Llc
II
Dec-01-2020
3
GE Healthcare, LLC
I
Jan-10-2020
4
Oridion Medical 1987 Ltd.
II
Oct-03-2018
5
Smiths Medical ASD Inc.
II
Jul-06-2018
6
Southmedic, Inc.
II
Jul-24-2021
7
Southmedic, Inc.
II
Jan-25-2018
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